All publications herein are incorporated by reference to the same extent as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference. The following description includes information that may be useful in understanding the present subject matter. It is not an admission that any of the information provided herein is prior art or relevant to the presently claimed subject matter, or that any publication specifically or implicitly referenced is prior art.
Endotracheal intubation involves the insertion of a flexible plastic tubular device, known as an endotracheal tube, into the trachea of a patient to protect the patient's airway and provide a means of mechanical ventilation. The most common method teaches the passing of an endotracheal tube, with the assistance of a laryngoscope, through the mouth, larynx, and vocal cords into the trachea, terminating at a position above the carina.
The primary purposes of endotracheal intubation, are to mechanically ventilate the patient's lungs, when a disease prevents the patient from normal, breathing induced ventilation, or to apply anesthetic gases during surgical intervention. In order to create enough air pressure to accomplish such mechanical ventilation and to prevent the escape of gases past the tube, it is necessary to seal the passageway around the endotracheal tube. A seal may be produced by the use of an inflatable cuff formed integrally with and surrounding the endotracheal tube. When the endotracheal tube has been introduced into the patient's trachea, the inflatable cuff will normally be located a few centimeters above the carina and within the tube-like trachea. The inflatable cuff is then inflated so as to engage the wall of the trachea and to help secure it in place and protect the airway from blood, vomit, and secretions. Gases may then be introduced through the endotracheal tube and into the lungs of the patient.
Although tracheal tubes have been effectively used in treating patients requiring respiratory ventilation, there exist several complications which may cause pneumonia, infections and other ailments when employing tracheal tubes.
In particular, many patients receiving endotracheal intubation develop complications, resulting from an infection of the lungs, possibly induced by contaminated, pooled secretions entering the trachea and the lungs. Infectious secretions may also reach the lungs upon cessation of mechanical ventilation, particularly when the need for endotracheal intubation ends and the inflatable cuff of the endotracheal tube is deflated allowing the infectious secretions, which have pooled above the inflatable cuff, to flow into the lungs. In certain instances, infectious secretions may reach the lungs during intubation, generally by aspiration of the secretions past the tracheal tube cuff.
Endotracheal suctioning is a common and effective procedure performed in patients receiving endotracheal intubation. In performing endotracheal suctioning, secretions accumulated in the tracheobronchital tree of the patient are cleared, leading to reduced incident and frequency of infection and other complications due to accumulation of secretions. In addition, endotracheal suctioning promotes optimal oxygenation of the lungs. However, endotracheal suctioning has been known to have adverse effects; primarily, the microbial contamination of the airway and lungs, and development of ventilator-associated pneumonia.
Two methods of endotracheal suctioning are currently available in the art, the open suction system and closed suction system. The open suction system (“OSS”) has been in use since the late 1970's, and is a single-use device intended to be disposed of after use. The open suction system requires the sealed ventilator circuit to be broken for enactment of endotracheal suctioning, allowing for possible contamination and infection of both the caregiver and the patient. The closed suction system (“CSS”) was introduced to limit the problems of contamination and infection associated with OSS and allow for the ventilator circuit to stay intact while performing endotracheal suctioning. In addition, CSS may be complemented with the integration of a suction tube within the tracheal tube to allow for the suction tube to remove pooled secretions from the pulmonary area via endotracheal suctioning, without disconnecting the patient from the ventilation system, thus reducing the incidence of infection.
Based on advantages such as lower incidence of ventilator associated pneumonia, fewer physiological disturbances, decreased microbiological contamination, and lower cost, CSS has become increasingly popular in the past decade, and accounts for the vast majority endotracheal suctioning used in the United States. (Paul-Allen et al., Survey of Nursing Practices With Closed-System Suctioning, American Journal of Critical Care, (January 2000), 9(1):9-17)
However, the progression of endotracheal suctioning methods from OSS to CSS, and further safe-guards produced in an attempt to reduce the rate of infection, have not entirely eliminated incidents of infection and contamination, and numerous patients continue to suffer from shortcomings employed in the current technology.
For example, CSS commonly employs a cavity found within the CSS system that allows a caregiver to inject liquid (such as saline) into the circuit or airway before, during or after the suction procedure. As the injection requires a break in the system, the CSS is compromised allowing for contamination. As a contaminated syringe, a contaminated liquid, or contaminated equipment associated with either the syringe or liquid, may be the culprit for infection, the incidence and possibility of disseminating a pathogen remains a primary health concern.
Furthermore, in the current CSS method, sterility may be compromised due to contact between a caretakers contaminated glove and the CSS cavity or syringe, when adding liquid or handling the CSS cavity (Blackwood et al., Closed Tracheal Suctioning Systems And Infection Control In The Intensive Care Unit, Journal Of Hospital Infection, (August 1998), 39(4):315-321). Accidental contamination as a result of improper cleaning procedures of the suction system is yet another cause of infection and contamination.
In both OSS and CSS, there exists the necessity to soften up the pooled secretions to ensure optimal removal via suction. In order to facilitate the removal of pooled secretions from the pulmonary area, a liquid solution, such as saline, is commonly administered to the pulmonary area to increase the efficacy of endotracheal suctioning. Saline solution has been shown to effectively “thin out” the secretions and to assist in their removal (Klockare et al., Comparison Between Direct Humidification And Nebulization Of The Respiratory Tract At Mechanical Ventilation: Distribution Of Saline Solution Studied By Gamma Camera, Journal of Clinical Nursing, (March 2006), 15(3):301-307). Once the secretions are thinned out, both the liquid and secretions are aspired from the trachea and surrounding areas by the chosen endotracheal suctioning means.
However, complications have arisen in connection with the administration and application of liquid solution to patients. Patients who have experienced endotracheal suctioning describe it as profoundly unpleasant and even a painful experience. The experience of saline instillation has been described as feeling “like I was drowning.” (Puchalski et al., Should Normal Saline be Used When Suctioning the Endotracheal Tube of the Neonate?, Medscape, Internet response posted Mar. 14, 2007. Unfortunately, this all too common experience is often caused by the over-administration of liquid to the patient by a caretaker.
As a result of the deficiencies prevalent in the current CSS and OSS methods, patients mechanically ventilated by tracheal devices remain at considerable risk for infection and contamination, diminishing the quality of care afforded to patients and causing unnecessary discomfort and pain (Kollef, M., Respiratory Failure: Complications of Mechanical Ventilation, ACP Medicine Online, (posted Sep. 1, 2002)). The incidence of infection and complications associated with infections are further exacerbated by the inaccurate administration of liquid solution, a common practice performed prior to endotracheal suctioning.
Accordingly, there exists a need in the art for devices and methods capable of substantially reducing the incidence of infection and spread of infectious agents during endotracheal intubation, as well as administering the precise quantity of liquid solution for secretion softening for improved suctioning.
The present subject matter addresses the inadequacies of current intubation methods by introducing a dedicated primary liquid reservoir attached to an endotracheal suctioning system by means of appropriate valves, and a volume measuring liquid chamber device, thus providing a composite closed suctioning and rinsing method that prevent uncontrolled flow of liquid. Because the design is truly closed, sterility is never compromised by exposing the system or introducing outside elements, such as liquid for rinsing, into the system. Furthermore, because the volume of liquid delivered for rinsing is controlled, the patient never receives an excess quantity of liquid.